TABLE 1.
Baseline demographics and patient characteristics in serum M‐protein population
| Isatuximab plus pomalidomide and dexamethasone (Isa‐Pd) (n = 128) | Pomalidomide and dexamethasone (Pd) (n = 128) | |
|---|---|---|
| Age, years (range) | 68 (36‐83) | 66 (41‐86) |
| Sex, n (%) | ||
| Female | 56 (44) | 72 (56) |
| Male | 72 (56) | 56 (44) |
| Weight (kg), median (range) | 74 (34‐110) | 73 (39‐140) |
| eGFR (mL/min), median (range) | 69 (30‐177) | 71 (31‐135) |
| R‐ISS, n (%) | ||
| I | 36 (28) | 28 (22) |
| II a | 81 (63) | 83 (65) |
| III | 11 (9) | 17 (13) |
| Serum β2‐microglobulin (mg/L), median (range) | 3.5 (1.1‐27) | 3.5 (0.7‐55) |
| Serum albumin (g/L), median (range) | 36.9 (16‐48.7) | 37 (16.5‐46.4) |
| Serum M‐protein at baseline (g/L), median (range) | 22 (5‐95) | 23 (5‐83) |
| Type of myeloma, n (%) | ||
| IgG | 97 (76) | 93 (73) |
| Non‐IgG | 31 (24) | 35 (27) |
| Plasmacytomas, n (%) | ||
| Yes | 13 (10) | 11 (9) |
| No | 115 (90) | 117 (91) |
| Cytogenetic risk at study entry, n (%) | ||
| Standard | 86 (67) | 63 (49) |
| High | 20 (16) | 33 (26) |
| Missing | 22 (17) | 32 (25) |
Abbreviations: e‐GFR, estimated glomerular filtration rate; R‐ISS, Revised Multiple Myeloma International Staging System (derived based on the combination of serum β2‐microglobulin, albumin, cytogenetic risk and lactate dehydrogenase).
a
As pre‐specified in the study statistical analysis plan, patients with unknown cytogenetics at baseline were classified as R‐ISS stage II.